NCCN Guidelines for Patients® | Chronic Myeloid Leukemia

25 NCCN Guidelines for Patients ® : Chronic Myeloid Leukemia, 2018 Clinical trials One of your treatment choices may be to join a clinical trial. Joining a clinical trial is strongly supported. NCCN believes that you will receive the best management in a clinical trial. New tests and treatments aren’t offered to the public as soon as they’re made. They first need to be studied. A clinical trial is a type of research that studies a test or treatment in people. Clinical trials study how safe and helpful tests and treatments are for people. When found to be safe and helpful, they may become tomorrow’s standard treatment. Because of clinical trials, the tests and treatments in this book are now widely used to help people with leukemia. Future tests and treatments that may have better results will depend on clinical trials. New tests and treatments go through a series of clinical trials. These trials aim to ensure they’re safe and work. Without clinical trials, there is no way to know if a test or treatment is safe or helpful. Clinical trials have four phases. Some examples of the four phases of treatment are: † † Phase I trials aim to find the safest and best dose of a new drug. Another aim is to find the best way to give the drug with the fewest side effects. These trials often involve about 20 people. † † Phase II trials assess if a drug works for a specific type of cancer. These trials often involve 20 to 100 people. † † Phase III trials compare a new drug to a standard treatment head-to-head. These trials often involve hundreds or thousands of people. † † Phase IV trials test drugs approved by the U.S. FDA to learn more about side effects with long- term use. Joining a clinical trial has benefits. First, you’ll have access to the most current cancer care. However, please note that it is unknown how well new treatments work if at all. Second, you will receive the best management of care. Third, the results of your treatment—both good and bad—will be carefully tracked. Fourth, you may help other people who will have cancer in the future. Clinical trials have risks, too. Like any test or treatment, there may be side effects. Also, new tests or treatments may or may not improve your health. In fact, your health may worsen during a trial. Other downsides may include more hospital trips, paperwork, and extra costs for you. To join a clinical trial, you must meet the conditions of the study. Patients in a clinical trial are often alike in terms of their cancer and general health. Thus, if patients improve, it’s because of the treatment and not because of differences between them. To join, you’ll need to review and sign an informed consent form. This form describes the study in detail. The study’s risks and benefits should be described and may include others than those described above. Ask your treatment team if there is an open clinical trial that you can join. There may be clinical trials where you’re getting treatment or at other treatment centers nearby. You can also find clinical trials through the websites listed in Part 6. 3 Overview of cancer treatments Clinical trials

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